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    • 2. 发明申请
    • ANTIBIOTIC COMPOSITIONS OF MODIFIED RELEASE AND PROCESS OF PRODUCTION THEREOF
    • 改性释放物的抗生素组合物及其生产方法
    • US20090111788A1
    • 2009-04-30
    • US12294353
    • 2007-03-07
    • Rajesh JainKour Chand JindalMunish Talwar
    • Rajesh JainKour Chand JindalMunish Talwar
    • A61K31/43A61K31/431A61K31/545A61K31/426A61K31/5383A61P11/00A61P31/04
    • A61K9/5026A61K9/284A61K9/286A61K9/2866A61K9/4866A61K9/4891A61K9/5047A61K31/424A61K31/43
    • Novel modified release pharmaceutical compositions wherein the composition comprises at least one antibiotic(s) preferably amoxicillin or its pharmaceutically acceptable salts, esters, polymorphs, isomers, prodrugs, solvates, hydrates, or derivatives thereof either alone or in combination with other antibiotic(s) as active ingredient, with at least one release modifying agent(s) for controlling the release of the beta lactam antibiotic optionally with one or more other pharmaceutically acceptable excipient(s) is provided, wherein the dosage form provides a release of not more than about 60% of the antibiotic in about 30 minutes and not less than about 70% of the antibiotic after 8 hours when subjected to in vitro dissolution study or when tested in vivo. Further, the compositions of the present invention which when tested in a group of healthy humans provide a mean peak plasma concentration (Cmax) after at least about 0.5 hour of administration of the dosage form. The present invention also provides process of preparing such dosage form and methods of using such dosage form.
    • 新型改性释放药物组合物,其中组合物单独或与其它抗生素组合包含至少一种抗生素,优选阿莫西林或其药学上可接受的盐,酯,多晶型物,异构体,前药,溶剂合物,水合物或衍生物, 作为活性成分,提供了至少一种用于控制任选与一种或多种其它药学上可接受的赋形剂释放β-内酰胺抗生素的释放调节剂,其中该剂型提供不超过约 在进行体外溶出研究或体内测试后8小时后,约30分钟内有60%的抗生素和不少于约70%的抗生素。 此外,当在一组健康人中测试时,本发明的组合物在施用剂型至少约0.5小时后提供平均峰值血浆浓度(C max)。 本发明还提供了制备这种剂型的方法和使用这种剂型的方法。